Legal & Regulatory

DSCSA verifies package movement, but resilience requires visibility into capacity, quality and sourcing risk.

Patient Advocate Foundation's Amy Niles on faster CMS prior authorization rules, Medicaid work requirements and what shrinking coverage means for patients.

DTP programs are outpacing regulatory guidance. Chander Viswanathan and Shannon Wiley, JD, make the case for compliance-by-design infrastructure over reactive fixes.

AMCP's Adam Colborn breaks down survey findings on how health plans and PBMs view the TrumpRx platform.

FDA is evaluating small pharmacies' package-level tracing capabilities while extending certain Drug Supply Chain Security Act exemptions to those dispensers through November 2027.

The Section 232 tariff deadline for 17 major drugmakers has arrived. Here's what pharma supply chain teams need to know now.

Domestic manufacturing can reduce certain dependencies, but reliable pharmaceutical commercialization requires qualified redundancy, sustainable economics, quality maturity and decision-ready visibility across the full supply network.

Four pharma commerce experts revisit their 2026 predictions on dealmaking, patient access and commercialization at the year's midpoint.

Gifthealth's Chip Parkinson says direct-to-patient adoption has accelerated since January, driven by structural, not cyclical, market forces.

Shortages of antibiotics, IV fluids and sterile injectables are hardening as new EU and US rules push pharma to fix the incentives behind them.

Amy Niles of the Patient Advocate Foundation on the Medicare Part D cap, Medicaid, ACA exchanges and rural hospital access in late 2026.

Amy Niles of the Patient Advocate Foundation on Medicaid work requirements, ACA subsidy expiration and patient affordability in 2026.

Amy Niles of the Patient Advocate Foundation revisits her 2026 outlook on prior authorization reform and the Medicare Prescription Payment Plan.

Novo Nordisk’s complaint argues that Lilly's campaigns leave out information about the most effective injectable doses of Wegovy (semaglutide) and Ozempic (semaglutide), a dispute that could reshape how both companies compete for share in the GLP-1 market.

Eli Lilly's acquisition of AtaiBeckley signals growing pharmaceutical industry commitment to psychedelic-based treatments for treatment-resistant depression.

The API Innovation Center's Gerren McHam on China's new supply chain rules, reshoring policy, and where US drug manufacturing goes next.

Germany's new health insurance law more than doubles mandatory drug rebates. Here is why it matters for US pharma pricing and launches.

As China tightens supply chain rules, tariff pressure persists, and the FDA's PreCheck Program takes shape, this FAQ breaks down how pharma reshoring stands in 2026.

Trutakna's FDA approval for IgAN highlights how patient support programs like TRU SUPPORT coordinate access and adoption in specialty drug launches.

Gerren McHam of the API Innovation Center on what a resilient US pharmaceutical supply chain looks like in five to ten years, and what execution actually requires.

The FDA selected seven companies, including two CGT manufacturers, for its PreCheck Pilot to accelerate domestic manufacturing approvals and bolster supply chain resilience.

Gerren McHam of the API Innovation Center outlines what a whole-of-government approach to meaningful pharmaceutical supply chain independence from China actually requires.

China's 2026 supply chain rules mean routine US trade compliance can now trigger Chinese export restrictions.

A US Section 301 probe into Germany's drug pricing could bring tariffs on APIs and finished drugs, raising new supply chain and pricing risks.

PwC's Philip Sclafani discusses oral GLP-1 cost exposure, oncology drug spend under the medical benefit, and his outlook on PBM reform.